Eye health firm Bausch + Lomb Corp. has recalled certain intraocular lenses or IOLs on its enVista platform following reports of complications, the cause of which could not immediately be explained, the U.S. Food and Drug Administration said.
The recall involves enVista Aspire, enVista Envy and certain enVista Monofocal Intraocular Lenses in the U.S.
All lots of the select enVista Aspire, enVista Aspire Toric, enVista Envy and enVista Envy Toric, as well as enVista monofocal and enVista monofocal Toric IOL models are affected in the recall.
The recall was issued following increased number of reports of toxic anterior segment syndrome or TASS, a potential complication in any cataract surgery.
TASS is an inflammatory reaction inside the eye that can have a variety of causes. When it occurs, the complication typically appears 12 - 48 hours after eye surgery. All enVista TASS cases reported to Bausch + Lomb to date responded quickly to treatment, and none have required removal of the lens.
Brent Saunders, chairman and CEO, Bausch + Lomb, said, "These reports represent only 1-2% of implanted lenses, with a positive prognosis for everyone involved. We look forward to identifying a root cause and bringing the enVista platform back to market."
The company is communicating with eye care professionals, with instructions for product return.
Cataract surgery patients experiencing eye discomfort are urged to contact their eyecare professional immediately; and Eyecare Professionals are asked to continue to closely monitor cataract surgery patients for at least 48 hours after surgery. If any new or worsening symptoms, they are required to instruct patients to contact their office immediately.
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